Table 2.

Patient demographics, baseline disease characteristics, and key efficacy outcomes. Mean (SD) are shown for both cohorts and summed total except calprotectin, which is shown as median values

Patients			Demographics			Baseline disease characteristics					Concomitant medications				Disease history				Key efficacy outcomes
Patients	Cohort	Dose (g/day)	Age	Race/ethnicity	Gender	Disease severity*	Extent of disease	Total Mayo score	Calprotectin (µg/g)	Short Inflammatory Bowel Disease Questionnaire score	5-ASA (%)	Glucocorticoids (%)	Anti-TNF (%)	Vedolizumab (%)	Failed anti-TNF (%)	Failed anti-TNF +vedolizumab (%)	Steroid dependent (%)	Colectomy recommended (%)	Clinical response (%)	Clinical remission (%)
1	1	0.5	58	WN	F	Mild	Left colon	4	N/A	14									X	X
2	1	0.5	48	WN	M	Moderate	Left colon	10	384	36		X		X	X	X	X	X	X
3	1	0.5	19	WN	M	Mild	Pancolitis	3	307	32		X		X	X	X	X	X	X	X
4	1	0.5	60	WN	F	Moderate	Pancolitis	9	>1000	60					X				X
5	2	1.5	68	WN	F	Moderate	Rectum and sigmoid colon	8	513	45	X	X							X
6	2	1.5	31	WN	M	Moderate	Left colon	10	728	28	X	X	X		X		X
7	2	1.5	19	WN	F	Moderate	Pancolitis	9	>1000	36		X		X	X	X	X		X
8	2	1.5	38	WN	M	Severe	Left colon	12	414	25				X	X	X		X	X
9	2	1.5	19	WN	M	Moderate	Left colon	9	478	42		X		X	X	X		X	X	X
10	2	1.5	14	WH	M	Moderate	Left colon	6	444	54		X	X		X				X
11	2	1.5	15	WH	F	Moderate	Left colon	8	N/A	24		X		X	X	X	X	X	X
Cohort 1			46 (16)					6.5 (3.0)	384	36 (16)	0	50	0	50	75	50	50	50	100	50
Cohort 2			29 (17)					8.9 (1.7)	496	36 (10)	29	86	29	57	86	57	43	43	86	14
Total			35 (19)					8.0 (2.6)	478	36 (13)	18	73	18	55	82	55	45	45	91	27

*Disease severity (Mayo score): mild (3–5), moderate (6–10), severe (11–12); WH, white, Hispanic or Latino; WN, white, not Hispanic or Latino.

5-ASA, 5-aminosalicylic acid; TNF, tumour necrosis factor.